Brussels, 26/09/2013 (Agence Europe) -Manufacturers of medical devices are not happy with the vote by the ENVI committee of the European Parliament on medical devices on 25 September. Provisions are aimed at providing a more robust examination of these devices and would compel manufacturers to introduce tougher inspections. In a press release, the European medical technology industry association Eucomed said that the Parliamentary committee had gone down the wrong path by creating a bureaucratic system that actually failed to achieve its objective of enhanced safety. It believes that although the initial proposal to introduce a preliminary system of authorisation for marketing had not been retained, the planned measures would in fact create such a system. The Parliamentary committee voted in favour of a heavily bureaucratic system with no proof of enhanced safety being provided and that it created wasteful delays in the provision of medical devices that were vitally important for patients. Eucomed also said that European innovation in the medical technology sector would be strangled as a result of this approach.
Health care without harm HCWH, the international organisation promoting a non-destructive medical practice in favour of individual health and environmental protection, however, welcomed this vote and described the approach adopted as, “a positive and necessary step towards implementing a non-toxic European health care system”. It particularly welcomed the adoption of amendments calling for the gradual phasing out of carcinogenic, mutagenic and toxic substances, as well as endocrine disrupting chemicals. This organisation also appreciates the ban on phthalates, which are contained in many medical devices. HCWH, however, deplores the fact that nano-materials are still tolerated.
Finally, the European Diagnostics Manufacturers Association (EDMA) (in vitro devices) welcomed the committee's vote on in vitro medical devices, which have the potential for improving the safety and quality of health care in Europe. Nonetheless, it believes that the three-year transition period is insufficient for introducing the new legislation and that it would have been better if they had had a more reasonable five-year transition period for compiling scientific data. (IL/transl.fl)